Build up of mucus, watery nasal secretions, phlegm and other bodily secretions in the human lungs/lung airways is a serious issue. In the US alone tens of millions of people every year suffer from breathing issues due to congested lung airways because there are a wide range of causes of such build ups. Chronic causes include a variety of diseases such as cystic fibrosis, asthma and COPD.
COPD (chronic obstructive pulmonary disease) impacts an estimated 30 million individuals in the US and is the third leading cause of death in the US, killing more than 130,000 people per year. COPD causes secretion buildup problems, exacerbated by the fact that COPD is usually seen in those with extensive damage to the airways and lungs due to long term smoking.
COPD is of particular interest in regard to coughing, in particular. A person with COPD may have problems with their abdominal muscles so that they have trouble coughing in an effective manner.
Another dangerous lung airway disease is Cystic Fibrosis. A defective gene in people with Cystic Fibrosis causes a thick, sticky buildup of mucus in the lungs, and in the pancreas, and even in other organs. In the lungs, the mucus clogs the airways and traps bacteria, leading to infections, extensive lung damage, and eventually respiratory failure. More than 30,000 people in the US are living with Cystic Fibrosis, and the majority of that population are minors under the age of 18.
Known machines for assisting people with Cystic Fibrosis do not allow children to wear the device simply because the device is too large. It would be preferable to provide a smaller, wearable machine, especially one small enough to be worn by children and yet allow a full range of activities. In addition, many types of machines rely upon electrodes implanted in the body and it would be preferable to provide a machine to children which does not require surgery and surgical implants.
Lung cancer in certain forms can cause mucus production to spike excessively, and painfully. Medications can cause excessive productions, allergies can, certain foods (dairy products, etc) can, and so on and so forth.
In addition to the serious, chronic long-term conditions discussed previously, short-term viral and bacterial infections such as the common cold and pneumonia and influenza (which once killed 50 to 100 million people in one single outbreak) can cause secretion buildups. The present invention is directed toward long-term problems such as COPD, but might be useful in therapy for short-term problems.
Unsurprisingly, medical and emergency workers have put a great deal of effort into trying to clear the human airways of bodily secretions which are benign in themselves (small amounts of mucus are produced by the throat constantly, and keep it moist and healthy) but which sometimes become dangerously excessive.
The excess secretions: the lungs are kept moist with a thin film of fluid to stop them drying out. When there is a chest infection or occasionally in other situations, this fluid increases and become thick or even putrid. In the normal situation, these secretions are removed by coughing but in the presence of chronic lung disease, this is not always possible. Although antibiotics may control the infection, they do not remove the secretions that occur. Some will be reabsorbed into the body but very thick ones will remain. It is important to remove the secretions to allow more effective breathing and increase the amount of oxygen getting into the body.
FIG. 1 is a perspective view of a PRIOR ART manual percussion method of mucus clearance 2. A wide number of techniques such as this have been tried over the centuries and presumably require no introduction. Even more extreme surgical procedures have been developed as well. These techniques to aid breathing or to clear mucus are not relevant to the present invention. Manual percussion techniques of chest physiotherapy have been used for a variety of diseases such as cystic fibrosis emphysema, asthma, and chronic bronchitis, to remove the excess secretions (also called mucus, phlegm, sputum) from inside the lungs. This treatments generally performed by physical therapists and respiratory therapists. Clearly this treatment has severe limitations in practicality and efficiency.
Mechanical/Pneumatic systems: in order to bypass dependency on Manual percussion techniques of chest physiotherapy, Mechanical/Pneumatic systems/chest compression devices have been developed to produce high frequency chest wall oscillations, and may be the most successful method of airway clearance developed prior to the present invention. However, the Mechanical/Pneumatic systems are very noisy and required large energy for the engines and blowers therefore are not energy efficient and require either electrical plug-ins, making them completely immobile, or a big battery for a few small hours of operation.
FIG. 2 is a perspective view of a PRIOR ART mechanical assistance device 4. This device, which effectively immobilizes the wearer, features a base unit, a portion worn on the chest, and a series of connections between them. Prior art mechanical device 4 is merely exemplary: devices are known which use not just pneumatic operation but other types of physical actuation of the lungs to assist with secretion clearance, or just to assist with ventilation, breathing, etc. This particular machine does not have a face mask depicted, but face masks are very common.
A newer method has been developed in recent decades for assisting with breathing, heart irregularities and so on. One example may be found in FIG. 3, which is a block diagram of a PRIOR ART implanted electrode method of stimulating the phrenic nerve. Prior art implanted electrode 6 (there may be several or just one) is implanted in the chest: it may be subdermal, or deep inside the thoracic cavity, it may be implanted to stimulate the heart or other muscles or it may be placed quite close to the phrenic nerve 8. The phrenic nerve 8 is frequently mentioned as being stimulated in prior art. Again, this machine may well deal with ventilation and simply not be relevant to the field of cough assistance.
Note that other implanted electrode devices may stimulate the diaphragm muscle so as to assist with breathing/ventilation, however, the present invention is about coughing assistance and does not stimulate the diaphragm anyway.
Pacemaker devices are an interesting analogy, although they do not deal with coughing assistance (indeed do not deal with ventilation anyway). A pacemaker device is not an artificial heart and thus is designed to assist the natural beating of the heart rather than to artificially impose heart operation.
Obviously implanting electrodes is very undesirable. Not only is a surgery required but the electrode is a foreign object in the body, with all the potential issues which may arise from that. The electrode cannot be easily checked or replaced, may degrade, and may be psychologically unwelcome to the patient.
Finally, although the phrenic nerve has proven to be a useful target for stimulation, it would be preferable to provide easier and more effective targets for stimulation.
It would be preferable to provide targets for cough assist stimulation which require no electrodes to be implanted at all.
It would further be preferable to provide a device and method of cough assisting which does not require or force the patient to cough but rather relies up on the bodies own cough reflex, assisting that natural autonomic cough mechanism rather than replacing it.
It would further be preferable to provide convenient control mechanisms so that not just medical professionals but patients themselves can monitor their own secretion clearance, coughing and other information and control it as necessary and practical.
It would further be preferable to provide a device and method which leaves the patient with a complete range of motion including mobility, uses small batteries, and allows essentially all normal activities.
It would further be preferable to provide a device and method which requires no face mask, no hoses, tubes or implanted electrodes. It would be preferable to provide a method which is fully electronic and yet requires no implantation or other surgery.
It would further be preferable to provide a device and method which operates by means of multiple different actions: small vibrations, larger muscle stimulations, options of different musculature usage and so on. Note that a diaphragm or heart stimulation technique by way of an implanted electrode has only a single choice of target, but the present invention is not so limited.
These and other aspects and objectives are addressed by the present invention.